(29 days)
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
The SelectCore™ Variable Throw Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The device offers the user the choice of either single fire or fully automatic modes. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.
The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the SelectCore™ Variable Throw Biopsy Device, which focuses on establishing substantial equivalence to a predicate device.
Specifically, the "Performance Testing Summary" section (in {1}) states: "Performance testing confirms that the quality of samples obtained with the SelectCore™ Variable Throw Biopsy Device is equivalent to that of the predicate device." However, it does not provide details on:
- Specific acceptance criteria: There are no defined numerical or qualitative targets for device performance.
- The study design: No information is given about how the "quality of samples" was assessed, what metrics were used, or what kind of study was conducted.
- Any of the requested details about sample size, ground truth, expert involvement, or comparative effectiveness.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide the detailed study information. The provided text does not contain this level of detail.
{0}------------------------------------------------
SECTION 5: 510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the logo for INRAD. The logo consists of a square with a diagonal line in the upper left corner, followed by the text "INRAD" in bold, sans-serif font. A small "R" in a circle is located in the upper right corner of the logo.
NOV 1 7 2009
November 9, 2009
Contact Information
Melissa Lalomia Director of Quality & Regulatory Affairs Phone: 616-301-7800, ext. 102 Fax: 616-301-7799 E-mail: mlalomia@inrad-inc.com
Company Information
Inrad, Inc 4375 Donker Court SE Kentwood, MI 49512 Phone: 616-301-7800 Fax: 616-301-7799
Device Name(s)
SelectCore™ Variable Throw Biopsy Device
Device Summary
Trade or Proprietary Name: SelectCore™ Variable Throw Biopsy Device Common or Usual Name: Biopsy Instrument Gastroenterology-urology biopsy instrument Classification Name: (21 CFR 876.1075, Product code KNW)
Name of Predicate(s) or Legally Marketed Device(s)
K960064 – Temno Achieve Biopsy Needle
Also known as:
Achieve® Programmable Automatic Biopsy System (Cardinal Health)
{1}------------------------------------------------
SECTION 5: 510(k) SUMMARY
Device Description
The SelectCore™ Variable Throw Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The device offers the user the choice of either single fire or fully automatic modes. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.
Indications for Use
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
Substantial Equivalence
The SelectCore™ Variable Throw Biopsy Device has the same intended use as the Achieve® Programmable Automatic Biopsy System. The device and the predicate device have the same technological characteristics in terms of design and materials.
Performance Testing Summary
Performance testing confirms that the quality of samples obtained with the SelectCore™ Variable Throw Biopsy Device is equivalent to that of the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple, sans-serif font. The logo is simple and professional, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 1 7 2009
Inrad, Inc. % Ms. Melissa Lalomia Director of Quality and Regulatory Affairs 4375 Donker Court SE Kentwood, Michigan 49512
Re: K093256
Trade/Device Name: SelectCore™ Variable Throw Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: November 10, 2009 Received: November 12, 2009
Dear Ms. Lalomia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{3}------------------------------------------------
Page 2 - Ms. Melissa Lalomia
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
for Peter Rimm
CEO Dir
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
SECTION 4: INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
SelectCore™ Variable Throw Biopsy Device
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
Prescription Use X (Part 21 CFR 801 Subpart D)
. AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
MilRP Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093256
Section 4 - 1
INRAD, INC. - CONFIDENTIAL
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.